Recurrent minor aphthous ulcers (of which canker sores are one type) are painful ulcers that develop inside the mouth. Canker sores are distinguished from other mouth ulcers by way of taking a history from a patient and by way of visual inspection. Typically there is no medical testing (i.e., biopsy or culturing) that is used to identify canker sores.
The hallmark characteristics of canker sores are their appearance, location, and the fact that they are recurrent. Canker sores form on the inside of the lips and cheeks, the floor of the mouth, the tongue, the soft palate, the tonsillar areas, and other areas in the mouth. The tissues surrounding a canker sore lesion will appear healthy and the patient will have no distinguishing systemic features (such as a fever or malaise).
A canker sore's earliest stage will be characterized by the formation of a reddish area on the skin in one of the locations described above. The area may be slightly elevated and it will often produce a tingling sensation. This initial lesion will subsequently degenerate into an ulcer that is round or oval in shape. The ulcer will usually be no more than a ¼ inch in diameter. The center of the ulcer will be covered with a loosely attached white or grayish membrane. The edges of the ulcer will be regular (not jagged) and surrounded by a reddish halo.
Canker sores usually are painful. It is common that the presence of a canker sore will interfere with eating and drinking or will cause a person to want to limit their oral movements. Canker sores normally last from ten days to two weeks. Usually this healing is uneventful with no residual scarring.
Once a person has initially experienced an outbreak of canker sores, the probability of recurrence is high, although the rate of recurrence is quite variable. A rate of one or two outbreaks per year would be considered typical (encompassing 50% of those who get canker sores). 30% of people who suffer from outbreaks of these lesions deal with their presence on a monthly basis. The number of outbreaks of canker sores a person experiences can vary greatly. Most persons will have only a few episodes a year while, at the other extreme, others will have nearly continuous outbreaks and will never be free of mouth ulcers for an extended period of time. A person's first canker sores typically appear between the ages of 10 and 20 years and then decrease in frequency and severity as the person ages. It's been estimated that roughly 20% of the general population experiences canker sores.
The precise mechanism by which canker sores form has not been definitively determined but it is likely that their development is related to a reaction of an individual's own immune system. Several triggers for canker sores have been identified.
Treatments for canker sores have included over the counter and prescription products. Such products include those which create a protective barrier film, those that numb the canker sore, etc. However, these products do not speed up the healing; they simply cover over and protect them. Antibacterial products may be used to prevent secondary infections from forming in the lesions. Anti-inflammatory medicines can help to minimize the extent to which a canker sore's ulceration will progress. Unfortunately, none of these treatments have proven particularly effective to speed healing, relieve pain, and reduce the frequency of recurrent minor aphthous ulcers, including canker sores.
Vitamin B12 is a cobalt-containing B complex vitamin that has various effects on biological processes in vivo. The majority of people do not need to take vitamin B12 supplements, however, vitamin B12 compounds have been available for many years as an injectable treatment for pernicious anemia, with daily doses typically in the range of 1000 micrograms. Vitamin B12 supplements are also known in the microgram range.
Vitamin B6 plays a role in a variety of biochemical reactions in the human body including the metabolism of amino acids and glycogen, the synthesis of nucleic acids, hemoglobin, sphingomyelin and other sphingolipids, and the biosynthesis of neurotransmitters including serotonin, dopamine, norepinephrine, and gamma-aminobutyric acid (GABA). Vitamin B6 is the primary vitamin for processing amino acids used in production of proteins and is also needed to make a variety of hormones including serotonin, melatonin, and dopamine. Typical doses of pyridoxine used for nutritional supplementation range from 2 to 20 milligrams/day.
Though Vitamin B6 in combination with folic acid and vitamin B12 have been known to control homocysteine levels which have been linked to heart disease, stroke, osteoporosis and Alzheimer's disease, no person has demonstrated that high doses of a vitamin B6 compound in combination with a vitamin B12 compound would achieve an enhanced therapeutic effect for the treatment of recurrent minor aphthous ulcers.
Accordingly, there has been a need for a novel method of treating minor aphthous ulcers which is safe and substantially effective at limiting their duration, lessening the pain and discomfort they cause, and reducing their recurrence. The present invention fulfills these needs and provides other related advantages.